Population-Based Cancer Registries in the United States: Usefulness in HPV Vaccine Monitoring Deblina Datta, MD National STD Prevention Conference March 11, 2008 My talk will focus on monitoring the outcomes of high-risk or oncogenic HPV infection, namely, anogenital cancers. Specifically, I will discuss the system of cancer surveillance in the US, which is based on a national network of cancer registries. I will focus my talk on the usefulness of cancer registries in their current role of monitoring HPV related cancers and briefly discuss plans to expand the role to include monitoring for cervical cancer precursors, an earlier manifestation of oncogenic HPV infection.

Cancers Attributable to Oncogenic HPV Infection Cervical cancer (12,000-13,000 cases/yr) Anal cancer Vulvar/Vaginal cancer Penile cancer Some head and neck cancers Approx. 20,000 cancer cases/year attributable to HPV infection This is a list of HPV related cancers. There are approximately 20,000 cases per year. Most are anogenital cancers, but a small number of head and neck cancers are included. It is important to note, that of these cancers, not all cases are due to HPV. Cervical cancer contributes the largest number of cases, approximately 12-13,000 cases per year, all of which are due to oncogenic HPV. However, less than half of all vulvar, vaginal, and penile cancer cases are associated with HPV, and only about 10% of head and neck cancers are associated.

Cancer Registration-What is it and how does it occur? Fundamental surveillance method for cancer in the US Population-based (state or metro area) Cases diagnosed by providers in hospital based registries Also diagnosed in non-hospital settings (physician offices, non-hospital based pathology labs, radiation centers, surgery centers, etc.) Cases registered by trained personnel (Certified Tumor Registrars) Reporting to state based registries either through Direct reporting Via regional registries Provide information for a national database of cancer incidence Cancer registration has been around in the US since the 1930’s and is the fundamental method of cancer surveillance in the US and many other countries. Cancer cases are diagnosed by providers in hospital based registries. Registries have expanded over the years to also register cases diagnosed in non-hospital settings such as physician offices, and non-hospital based pathology labs, radiation treatment centers and surgery centers. All cases are registered by certified tumor registrars and reported to to state based central cancer registries, also known as population-based registries either through direct reporting or via regional registries. These data are transmitted to federal agencies to compile a national database of cancer incidence and mortality.

Types of Data Collected through Cancer Registries Reports of incident cases Demographics Primary anatomic site of cancer Cancer histologic type Extent of disease at the time of diagnosis (stage) Planned first course of treatment Outcome of treatment and clinical management (survival and vital status) This is a list of the different types of data collected through cancer registries. They include reports of incident cancer cases, demographics of the patients, and various characteristics of the cancer and cancer treatment. Data on mortality from vital records are also integrated into the data.

Population-based Cancer Registries: Functions Measure burden of cancer in a well defined geographic area (typically a state) Monitor cancer trends over time Determine cancer patterns in various populations (e.g. racial disparities) Guide planning and evaluation of cancer control and prevention programs Guide priority-setting for allocating health resources Advance clinical, epidemiologic, and health services research around cancer in the US The functions of population-based cancer registries are to: Measure burden of cancer in a well defined geographic area (typically a state) Monitor cancer trends over time Determine cancer patterns in various populations (e.g. racial disparities) Guide planning and evaluation of cancer control and prevention programs Guide priority-setting for allocating health resources Advance clinical, epidemiologic, and health services research around cancer in the US

National Cancer Registration in the US: Structure of the System Federal Agencies-Data Collection and Dissemination, based on Congressional Acts NCI, Surveillance, Epidemiology, and End Results (SEER) program, estab 1971 CDC, National Program of Cancer Registries (NPCR), estab 1992 Non-profit Organization-Establish and Maintain Data Standards North American Association of Central Cancer Registries (NAACCR) Cancer registration is supported mainly by three entities: two federal agencies and one umbrella non-profit agency. The federal agencies are responsible for funding and operating state based registires and include CDC, which funds and operates the National Program of Cancer Registries, or NPCR and NCI, which funds and operates the Surveillance Epidemiology and End Results program, or SEER. Both NPCR and SEER programs include state based registries which together cover 100% of the US population and I will discuss each of them in more detail shortly. NAACCR is the …. and plays an active role in: Education and training of registry personnel Developing and maintaining uniform data standards across registries in both NPCR and SEER Certification of complete, timely, and accurate data Promoting the use of cancer data

Cancer Registries in the US: 100% Population Coverage by NPCR and SEER This map displays the 100% population coverage provided by the NPCR and SEER registries. The NPCR registries are shown in yellow, and constitute a large number of these registries. The SEER registries are shown in white and include a some states as well as several metropolitan areas. A few states, shown in orange have registries funded both by SEER and NPCR.

Invasive Cervical Cancer Incidence Counts and Age-Adjusted Invasive Cervical Cancer Incidence Rates, US, 2002-2004 Count Rate All Races 34,806 8.3 White 27,176 7.8 Black 5,291 11.6 Asian/Pacific Islander 1,381 7.5 American Indian/Alaska Native 248 6.3 Hispanic* 5,578 13.0 *Hispanic origin is not mutually exclusive from race categories (white, black).

Cervical Cancer Precursors Data Collection in NPCR: Background Some previous experience collecting cervical carcinoma in situ (CIS/CIN 3) Decision to discontinue collection of CIS data in 1996 based on concerns over new nomenclature and misclassification of cases Michigan Central Cancer Registry has continued to collect CIS data While the registries have a well-established role in measuring invasive cancer cases, a newer potential role is to collect data on cervical cancer precursor lesions. Cervical cancer precursor lesions are earlier manifestations of oncogenic HPV infection and afford an opportunity measure the impact of HPV vaccine for outcomes which occur 5-10 years after HPV infection (in contrast to the several decades between HPV infection and invasive cancer outcomes. One precursor lesion, Carcinoma in situ, which is also referred to as CIS or CIN3, has been previously monitored in the registries.

Rates* of Invasive Cervical Cancer and CIS, Michigan, 1985-2003 *Rates per 100,000 persons Data courtesy of MI Central Cancer Registry

Age Specific CIS Rates*, Michigan, 1985-2003 *Rates per 100,000 persons Data courtesy of MI Central Cancer Registry

Current Directions: Cervical Cancer Precursors Data Collection in NPCR Three central cancer registries Michigan Central Cancer Registry (NPCR and SEER, geographically distinct sites) Louisiana Tumor Registry (NPCR and SEER) Kentucky Central Cancer Registry (NPCR and SEER) Leverage infrastructure Experienced tumor registrars Data streams from pathology labs (and other sources) Apply data standards for completeness, accuracy, timeliness

Current Directions: Cervical Cancer Precursors Data Collection in NPCR Collection of incidence data on CIN2/3 vs. CIN 3 vs. CIS in population-based registries Additional data elements Race and ethnicity Age Zip code Electronic data reporting Linkage with vaccine registries (Michigan) for vaccination history

Current Directions: HPV Typing of Cervical Cancers in NPCR Approx 12,000 cervical cancer cases reported per year in NPCR 4 state-based central cancer registries Addition of Florida Collection of pathology specimens from a sample of cancer cases to be sent to CDC for HPV typing

Acknowledgements Michigan Central Cancer Registry CDC Glenn Copeland Cheryl Cardinez Mona Saraiya Hillard Weinstock The findings and conclusions in this presentation are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention

For more information: NPCR http://www.cdc.gov/cancer/npcr/ SEER http://seer.cancer.gov/